MAUDE Adverse Event Report: ZIMMER GMBH SCREW FOR 75.11.00-05

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant product(s): tri-shank flex shaft, tem#00-8790-007-05, lot# unknown.As for zimmer specialists to perform an in-depth analysis it is required to have all necessary information at hand, it was therefor tried several times to receive more information for this case.Additional information was requested at complainant and is currently not available.As no lot numbers were provided for the devices, the device history records could not be reviewed.An e-mail requesting missing device data information was sent to the complainant.At zimmer (b)(4) all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer (b)(4) and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Trend analysis: no trend considering the following event is identified: screw loose.No trend analysis on the lot number could be performed, as it remains unknown.Event summary: it was reported that a flexible shaft could not be used during surgery because the screw would not lock it as it is loose.The surgery was successfully completed with another screwing system with a delay of 15-30 minutes.No medical data such as surgical notes or any other case-relevant documents received.No product was returned to zimmer biomet for in-depth analysis.According to the information received, the product location is unknown.Review of product documentation: - instruction for use (ifu): packaging insert ifu states ¿after cleaning, lubricate metal, moving parts with a water soluble lubricant approved for use with medical devices.Reassemble and tighten screws where appropriate¿.Root cause analysis: root cause determination using rmw: - instrument, breaks, deforms, diverge, or parts remain in wound.Due to inadequate design for intended performance not possible.A systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.- instrument, breaks, deforms, diverge, or parts remain in wound.Due to mechanical properties of material insufficient not possible.A systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.- instrument cannot be used with the mating instrument or mating implant as intended due to failure of instrument mating condition.Possible, as a deterioration in function as a result of repeated use cannot be excluded.The manufacturing date of the instruments is unknown.- damaged instruments, implants, body or wrong operational step due to surgeon or operating room staff unfamiliar with instrument usage and handling.Possible, as a deterioration in function as a result of repeated use cannot be excluded.The manufacturing date of the instruments is unknown.Additionally, the screw is not supposed to be unscrewed from the flexible shaft.- damaged instruments, implants, body or wrong operational step due to surgeon or operating room staff unfamiliar with instrument usage and handling.Possible, as it cannot be excluded based on the available information.The screw is not supposed to be unscrewed from the flexible shaft.Conclusion summary: neither the products nor the lot numbers were available for the investigation.Therefore the event could not be recreated and it is unclear how the screw could "unlock".Generally it needs to be considered that the locking screw should not be unscrewed completely from the instrument for cleaning and disinfection.This would only be possible by turning the screw clockwise.In order to have an appropriate cleaning and disinfection of the whole instrument it is sufficient to loosen the screw (counter-clockwise) but it should always remain within the flex shaft.However, as the instruments have not been returned for an investigation, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer biomet considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).The following report is associated with this event: 0009613350 - 2017 - 01431.

Event Description

It was reported that during the surgery the flexible shaft to engage the tip was unusable because the screw that should lock it unscrews and loses.The surgery has been completed with delay ( 15-30 minutes), time used to find another screwing system.Notes: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.

• Brand Name: SCREW FOR 75.11.00-05
• Type of Device: NA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7330252
• MDR Text Key: 102220868
• Report Number: 0009613350-2018-00342
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 75.11.01-05
• Device Lot Number: UNKNOWN
• Other Device ID Number: 00889024302754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1